St. Jude Medical ICD & CRT-D Battery Lawsuit

Filing a St. Jude Medical ICD & CRT-D battery lawsuit could be an option if you or a loved one were impacted by a recent recall for certain cardiac devices related to a battery depletion issue. The Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators affected by this problem may not deliver needed therapy if a battery fails prematurely, a scenario that could prove deadly.

Free Legal Reviews for St. Jude Medical ICD & CRT-D Recipients

The attorneys at Bernstein Liebhard LLP are offering fee legal reviews to individuals who suffered adverse events following premature ICD or CRT-D battery depletion, as well as those who required replacement of a St. Jude Medical device due to this issue. To learn more, please call (888) 994-5118.

St. Jude ICD & CRT-D Battery: What’s the Problem?

The St Jude Medical ICD & CRT-D battery recall was announced in October 2016, after St. Jude received numerous reports of batteries that had been depleted early. If the battery fails prematurely, the ICD or CRT-D will not be able to provide needed shock therapy. So far, two deaths (1 in the U.S.) have been linked to this problem. Ten additional patients, (9 in the U.S), reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion. Another 37 (30 in the U.S.) have reported dizziness.

According to the U.S. Food & Drug Administration (FDA), of the 398,740 ICDs and CRT-Ds sold worldwide, 841 have been returned to St. Jude for analysis due to premature battery depletion.

What Device Were Involved in this Recall?

All of the ICDs and CRT-Ds involved in this action were manufactured prior to May 2015.  The recall includes:

  • Fortify VR
  • Fortify ST VR
  • Fortify Assura VR
  • Fortify Assura ST VR
  • Fortify DR
  • Fortify ST DR
  • Fortify Assura DR
  • Fortify Assura ST DR
  • Unify
  • Unify Quadra
  • Unify Assura
  • Quadra Assura
  • Quadra Assura MP

The FDA indicated that 349,852 affected devices remain actively implanted in patients worldwide. Recipients of the above ICD and CRT-D products can visit St. Jude Medical’s website to determine if their device is included in the recall.

St. Jude Recall and Merlin@home

The U.S. Food & Drug Administration (FDA) has recommended, among other things, that patients with the affected implants register for St. Jude Medical’s Merlin@home monitoring in order to monitor their devices for premature battery failure. However, this could prove problematic, as it was recently alleged that the Merlin@home system is vulnerable to hacking.  In fact, at the time of St. Jude’s battery recall, the FDA and the U.S. Department of Homeland Security were actively investigating these allegations.

“Despite the allegations, at this time, the FDA strongly recommends that the Merlin@Home device be used to monitor the battery for these affected devices because the benefits of continued patient monitoring and the life-saving therapy these devices provide greatly outweighs any potential cybersecurity vulnerabilities,” the FDA said in a statement.

How Can Filing a Lawsuit Help?

Individuals affected by this recall are at risk for serious complications should their ICD or CRT-D fail to provide needed therapy due to premature battery failure. The FDA has also cautioned that recommended mitigations may not be sufficient for some patients, such as those that are dependent upon their device for pacing with an untolerated or absent intrinsic heart rate. “Health care providers should consider whether elective device replacement is warranted for their pacemaker dependent patients,” the FDA said.

Filing a St. Jude Medical ICD & CRT-D battery lawsuit could help injured patients, as well those forced to undergo device replacement, obtain compensation for medical bills, lost wages, pain and suffering, and any other damages they incurred due to this issue. If you would like to explore possible legal action, please call (888) 994-5118 to discuss your case with a member of our staff.

  1. FDA (2016) “Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices: FDA Safety Communication”
  2. Jude (2016) “Global Medical Advisory Concerning Subset of ICD and CRT-D Devices”
  3. Reuters (2016) “Two deaths spark recall of St. Jude heart devices”
Last Modified: October 14, 2016

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